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Association of Clinical Trials Organizations (ACTO)
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

Home  >  Analytics & Media  >  Press Releases  >  Moscow, April 1, 2009 - ACTO comments on the practice of delegating power on ethical review by institutional ethics committees to the federal Ethics Committee



Moscow, April 1, 2009
ACTO comments on the practice of delegating power on ethical review by institutional ethics committees to the federal Ethics Committee

Some time ago institutional ethics committees began to appeal to the federal Ethics Committee in order to delegate power on ethical review. In some cases we are talking about complete delegation of power. In some cases institutional ethics committees want to abandon a clinical trial after having approved it and delegate power on receiving information about clinical trial, including information about adverse events, amendments to the protocol, to the informed consent form etc. In all these cases there is no will of the federal Ethics Committee to adopt the delegated power.

The above mentioned practice is a concern for conscientious clinical research market players. ACTO considers it necessary to bring its position on this issue to the notice of stakeholders.

In accordance with Russian legislation, the delegation of power between the subjects of legal relations shall be carried out only in cases specified in the law (vertically - when there is relationship of subordination, horizontally - on the basis of contractual relations).

According to ICH GCP ethics committees are independent expert bodies established at institutional, regional, national or supranational level. The independence of ethics committees makes it intolerable to create a system of subordination. Thus, the power of a committee may not be delegated to another one on the principle of subordination.

As far as we know, contractual relations in whom the federal Ethics Committee agrees to accept the delegated power are absent.

Thus, the delegation of power by local ethics committees to the federal Ethics Committee contradicts Russian legislation because there is no basis for the emergence of mutual rights and responsibilities.

It should also be noted that ethics committees operating in compliance with ICH GCP should provide not only initial expert review of a trial protocol, but also ensure the protection of the rights, safety and well-being of trial subjects in the course of the trial.

ACTO finds it necessary to emphasize the inadmissibility of the delegation of power on ethical review by institutional ethics committees to the federal Ethics Committee.

 


 
   
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